Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability, 47211-47216 [2011-19806]
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Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from April 1, 2011, through
June 30, 2011. There were no denial
actions during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
2011, THROUGH JUNE 30, 2011
PMA No./Docket No.
Applicant
Trade name
Approval date
P050050 FDA–2011–M–0323 .......
P060004(S1) FDA–2011–M–0256
P100040 FDA–2011–M–0257 .......
H100002 FDA–2011–M–0241 .......
P100018 FDA–2011–M–0284 .......
Small Bone Innovations, Inc .........
Carl Zeiss Meditec, Inc .................
Medtronic Vascular .......................
NeuroVasx, Inc .............................
Chestnut Medical Technologies,
Inc.
NovoCure, Ltd ...............................
Roche Molecular Systems, Inc .....
St. Jude Medical, Inc ....................
Boston Scientific Corp ..................
Scandinavian total ankle replacement system .........
Meditec MEL 80 excimer laser system ....................
Valiant thoracic stent graft system ...........................
cPAX aneurysm treatment system ...........................
Pipeline embolization device ....................................
May 27, 2009.
March 28, 2011.
April 1, 2011.
April 1, 2011.
April 6, 2011.
April
April
April
April
Alcon Research, Ltd .....................
NovoCure Ltd.’s NovoTTF–100A treatment kit ........
cobas HPV test .........................................................
Trifecta heart valve ...................................................
ION paclitaxel-eluting coronary stent system (monorail and over-the-wire systems).
AcrySof toric IOL and AcrySof IQ toric IOL ..............
P100034
P100020
P100029
P100023
FDA–2011–M–0295
FDA–2011–M–0300
FDA–2011–M–0296
FDA–2011–M–0342
.......
.......
.......
.......
8, 2011.
19, 2011.
20, 2011.
22, 2011.
P930014 (S45) FDA–2011–M–
0338.
P040012 (S34) FDA–2011–M–
0343.
P090028 FDA–2011–M–0348 .......
Abbott Vascular, Inc ......................
RX Acculink carotid stent system .............................
May 6, 2011.
Ortho-Clinical Diagnostics, Inc ......
May 11, 2011.
P100017 FDA–2011–M–0349 .......
Abbott Molecular, Inc ....................
P100013 FDA–2011–M–0430 .......
P070015 (S54) FDA–2011–M–
0431.
Cordis Corp ...................................
Abbott Vascular .............................
P100014
P090002
P100027
P100031
.......
.......
.......
.......
Oceana Therapeutics, Inc .............
Depuy Orthopaedics, Inc ..............
Ventana Medical Systems, Inc .....
Roche Diagnostics Corp ...............
P100032 FDA–2011–M–0503 .......
Roche Diagnostics Corp ...............
Vitros immunodiagnostic products HBeAg reagent
pack/products HBeAg calibrator/products HBe
controls.
Abbott RealTime HCV, Abbott RealTime HCV amplification reagent kit, Abbott RealTime HCV control kit, Abbott RealTime HCV calibrator kit, and
optional UNG Uracil-N-glycosylase.
Cordis ExoSeal vascular closure device ..................
Xience nano everolimus-eluting coronary stent system and Promus everolimus-eluting coronary
stent system.
Solesta injectable gel ................................................
Pinnacle complete acetabular hip system ................
INFORM HER2 dual ISH DNA probe cocktail ..........
Elecsys anti-HBc immunoassay and Elecsys
PreciControl anti-HBc for use on the modular
Analytics E170 immunoassay analyzer.
Elecsys anti-HBc immunoassay and Elecsys
PreciControl anti-HBc for use on the Elecsys
2010 immunoassay analyzer.
FDA–2011–M–0445
FDA–2011–M–0470
FDA–2011–M–0472
FDA–2011–M–0502
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Food and Drug Administration
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Dated: July 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[Docket No. FDA–2011–N–0332]
[FR Doc. 2011–19734 Filed 8–3–11; 8:45 am]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability
BILLING CODE 4160–01–P
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
Under the Food and Drug
Administration Modernization Act of
1997 (Modernization Act), the Food and
SUMMARY:
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May 3, 2011.
May 17, 2011.
May 19, 2011.
May 24, 2011.
May 27, 2011.
June 13, 2011.
June 14, 2011.
June 22, 2011.
June 27, 2011.
Drug Administration (FDA) is required
to report annually in the Federal
Register on the status of postmarketing
requirements and commitments
required of, or agreed upon by, holders
of approved drug and biological
products. This notice is the Agency’s
report on the status of the studies and
clinical trials that applicants have
agreed to, or are required to, conduct.
Beth
Duvall-Miller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6466,
Silver Spring, MD 20993–0002, 301–
796–0700; or Stephen Ripley, Center for
FOR FURTHER INFORMATION CONTACT:
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Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1400 Rockville Pike,
Rockville, MD 20852, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Modernization Act
Section 130(a) of the Modernization
Act (Pub. L. 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new
provision requiring reports of certain
postmarketing studies, including
clinical trials, for human drug and
biological products (section 506B of the
FD&C Act (21 U.S.C. 356b)). Section
506B of the FD&C Act provides FDA
with additional authority to monitor the
progress of a postmarketing study or
clinical trial that an applicant has been
required to, or has agreed to, conduct by
requiring the applicant to submit a
report annually providing information
on the status of the postmarketing
study/clinical trial. This report must
also include reasons, if any, for failure
to complete the study/clinical trial.
These studies and clinical trials are
intended to further define the safety,
efficacy, or optimal use of a product,
and therefore play a vital role in fully
characterizing the product.
Under the Modernization Act,
commitments to conduct postmarketing
studies or clinical trials included both
studies/clinical trials that applicants
agreed to conduct, as well as studies/
clinical trials that applicants were
required to conduct under FDA
regulations.1
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B. The Food and Drug Administration
Amendments Act of 2007
On September 27, 2007, the President
signed Public Law 110–85, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA). Section 901, in Title
IX of FDAAA, created a new section
505(o) of the FD&C Act authorizing FDA
to require certain studies and clinical
trials for human drug and biological
products approved under section 505 of
the FD&C Act or section 351 of the
Public Health Service Act. Under
1 Before passage of the Food and Drug
Administration Amendments Act of 2007 (FDAAA),
FDA could require postmarketing studies and
clinical trials under the following circumstances:
To verify and describe clinical benefit for a human
drug approved in accordance with the accelerated
approval provisions in section 506(b)(2)(A) of the
FD&C Act (21 CFR 314.510 and 601.41); for a drug
approved on the basis of animal efficacy data
because human efficacy trials are not ethical or
feasible (21 CFR 314.610(b)(1) and 601.91(b)(1));
and for marketed drugs that are not adequately
labeled for children under section 505B of the
FD&C Act (Pediatric Research Equity Act (21 U.S.C.
355c; Pub. L. 108–155)).
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FDAAA, FDA has been given additional
authority to require applicants to
conduct and report on postmarketing
studies and clinical trials to assess a
known serious risk, assess signals of
serious risk, or identify an unexpected
serious risk related to the use of a
product. This new authority became
effective on March 25, 2008. FDA may
now take enforcement action against
applicants who fail to conduct studies
and clinical trials required under
FDAAA, as well as studies and clinical
trials required under FDA regulations
(see sections 505(o)(1), 502(z), and
303(f)(4) of the FD&C Act (21 U.S.C.
355(o)(1), 352(z), and 333(f)(4))).
Although regulations implementing
the Modernization Act postmarketing
authorities use the term ‘‘postmarketing
commitment’’ to refer to both required
studies and studies applicants agree to
conduct, in light of the new authorities
enacted in FDAAA, FDA has decided it
is important to distinguish between
enforceable postmarketing requirements
and unenforceable postmarketing
commitments. Therefore, in this notice
and report, FDA refers to studies/
clinical trials that an applicant is
required to conduct as ‘‘postmarketing
requirements’’ (PMRs) and studies/
clinical trials that an applicant agrees to
but is not required to conduct as
‘‘postmarketing commitments’’ (PMCs).
Both are addressed in this notice and
report.
C. FDA’s Implementing Regulations
On October 30, 2000 (65 FR 64607),
FDA published a final rule
implementing section 130 of the
Modernization Act. This rule modified
the annual report requirements for new
drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) by revising § 314.81(b)(2)(vii)
(21 CFR 314.81(b)(2)(vii)). The rule also
created a new annual reporting
requirement for biologics license
applications (BLAs) by establishing
§ 601.70 (21 CFR 601.70). The rule
described the content and format of the
annual progress report, and clarified the
scope of the reporting requirement and
the timing for submission of the annual
progress reports. The rule became
effective on April 30, 2001. The
regulations apply only to human drug
and biological products approved under
NDAs, ANDAs, and BLAs. They do not
apply to animal drugs or to biological
products regulated under the medical
device authorities.
The reporting requirements under
§§ 314.81(b)(2)(vii) and 601.70 apply to
PMRs and PMCs made on or before the
enactment of the Modernization Act
(November 21, 1997), as well as those
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made after that date. Therefore, studies
and clinical trials required under
FDAAA are covered by the reporting
requirements in these regulations.
Sections 314.81(b)(2)(vii) and 601.70
require applicants of approved drug and
biological products to submit annually a
report on the status of each clinical
safety, clinical efficacy, clinical
pharmacology, and nonclinical
toxicology study/clinical trial either
required by FDA or that they have
committed to conduct, either at the time
of approval or after approval of their
NDA, ANDA, or BLA. The status of
PMCs concerning chemistry,
manufacturing, and production controls
and the status of other studies/clinical
trials conducted on an applicant’s own
initiative are not required to be reported
under §§ 314.81(b)(2)(vii) and 601.70
and are not addressed in this report. It
should be noted, however, that
applicants are required to report to FDA
on these commitments made for NDAs
and ANDAs under § 314.81(b)(2)(viii).
Furthermore, section 505(o)(3)(E) of the
FD&C Act, as amended by FDAAA,
requires that applicants report
periodically on the status of each
required study/clinical trial and each
study/clinical trial ‘‘otherwise
undertaken * * * to investigate a safety
issue * * *.’’
According to the regulations, once a
PMR has been required, or a PMC has
been agreed upon, an applicant must
report on the progress of the PMR/PMC
on the anniversary of the product’s
approval until the PMR/PMC is
completed or terminated and FDA
determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either
no longer feasible or would no longer
provide useful information. The annual
progress report must include a
description of the PMR/PMC, a schedule
for completing the PMR/PMC, and a
characterization of the current status of
the PMR/PMC. The report must also
provide an explanation of the PMR/PMC
status by describing briefly the progress
of the PMR/PMC. A PMR/PMC schedule
is expected to include the actual or
projected dates for the following:
(1) Submission of the final protocol to
FDA, (2) completion of the study/
clinical trial, and (3) submission of the
final report to FDA. The status of the
PMR/PMC must be described in the
annual report according to the following
definitions:
• Pending: The study/clinical trial
has not been initiated (i.e., no subjects
have been enrolled or animals dosed),
but does not meet the criteria for
delayed (i.e., the original projected date
for initiation of subject accrual or
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initiation of animal dosing has not
passed);
• Ongoing: The study/clinical trial is
proceeding according to or ahead of the
original schedule;
• Delayed: The study/clinical trial is
behind the original schedule;
• Terminated: The study/clinical trial
was ended before completion, but a
final report has not been submitted to
FDA; or
• Submitted: The study/clinical trial
has been completed or terminated, and
a final report has been submitted to
FDA.
Databases containing information on
PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research
(CDER) and the Center for Biologics
Evaluation and Research (CBER).
II. Summary of Information From
Postmarketing Status Reports
This report, published to fulfill the
annual reporting requirement under the
Modernization Act, summarizes the
status of PMRs and PMCs as of
September 30, 2010. If a requirement or
commitment did not have a schedule, or
a postmarketing progress report was not
received in the previous 12 months, the
PMR/PMC is categorized according to
the most recent information available to
the Agency.2
Information in this report covers any
PMR/PMC that was made, in writing, at
the time of approval or after approval of
an application or a supplement to an
application, including PMRs required
under FDAAA (section 505(o)(3) of the
FD&C Act), PMRs required under FDA
regulations (e.g., PMRs required to
demonstrate clinical benefit of a product
following accelerated approval (see
footnote 1 of this document)), and PMCs
agreed to by the applicant.
Information summarized in this report
includes the following: (1) The number
of applicants with open (uncompleted)
PMRs/PMCs, (2) the number of open
PMRs/PMCs, (3) the status of open
PMRs/PMCs as reported in
§ 314.81(b)(2)(vii) or § 601.70 annual
reports, (4) the status of concluded
PMRs/PMCs as determined by FDA, and
(5) the number of applications with
open PMRs/PMCs for which applicants
did not submit an annual report within
60 days of the anniversary date of U.S.
approval.
Additional information about PMRs/
PMCs submitted by applicants to CDER
and CBER is provided on FDA’s Web
site at https://www.fda.gov/Drugs/
2 Although the data included in this report do not
include a summary of reports that applicants have
failed to file by their due date, the Agency notes
that it may take appropriate regulatory action in the
event reports are not filed on a timely basis.
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GuidanceComplianceRegulatory
Information/Post-marketing
PhaseIVCommitments/default.htm.
Neither the Web site nor this notice
include information about PMCs
concerning chemistry, manufacturing,
and controls. It is FDA policy not to
post information on the Web site until
it has been reviewed for accuracy.
Numbers published in this notice
cannot be compared with the numbers
resulting from searches of the Web site
because this notice incorporates totals
for all PMRs/PMCs in FDA databases,
including PMRs/PMCs undergoing
review for accuracy. In addition, the
report in this notice will be updated
annually while the Web site is updated
quarterly (i.e., in January, April, July,
and October).
Many applicants have more than one
approved product and for many
products there is more than one PMR or
PMC. Specifically, there were 164
unique applicants with 233 NDAs/
ANDAs that had open PMRs/PMCs.
There were 69 unique applicants with
87 BLAs that had open PMRs/PMCs.
Annual status reports are required to
be submitted for each open PMR/PMC
within 60 days of the anniversary date
of U.S. approval of the original
application. In fiscal year 2010 (FY10),
20 percent (36/184) of NDA/ANDA and
36 percent (31/87) of BLA annual status
reports were not submitted within 60
days of the anniversary date of U.S.
approval of the original application. Of
the annual status reports due but not
submitted on time, 100 percent of the
NDA/ANDA and 52 percent (16/31) of
the BLA reports were submitted before
the close of FY10 (September 30, 2010).
Most PMRs are progressing on
schedule (91 percent for NDAs/ANDAs;
88 percent for BLAs). Most PMCs are
also progressing on schedule (84 percent
for NDAs/ANDAs; 77 percent for BLAs).
Most of the PMCs that are currently
listed in the database were developed
before the postmarketing requirements
section of FDAAA took effect.3
III. About This Report
This report provides six separate
summary tables. The tables in this
document distinguish between PMRs
and PMCs and between on-schedule and
off-schedule PMRs and PMCs according
to the original schedule milestones. Onschedule PMRs/PMCs are categorized as
pending, ongoing, or submitted. Off3 There are existing PMCs established before
FDAAA that might meet current FDAAA standards
for required safety studies/clinical trials under
section 505(o)(3)(B) of the FD&C Act. Under section
505(o)(3)(c) of the FD&C Act, the Agency may
convert pre-existing PMCs into PMRs if it becomes
aware of new safety information.
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schedule PMRs/PMCs that have missed
one of the original milestone dates are
categorized as delayed or terminated.
The tables include data as of September
30, 2010.
Table 1 of this document provides an
overall summary of the data on all PMRs
and PMCs. Tables 2 and 3 of this
document provide detail on PMRs.
Table 2 of this document provides
additional detail on the status of onschedule PMRs.
Table 1 of this document shows that
most PMRs (91 percent for NDAs/
ANDAs and 88 percent for BLAs) and
most PMCs (84 percent for NDAs/
ANDAs and 77 percent for BLAs) are on
schedule. Overall, of the PMRs that are
pending (i.e., have not been initiated),
92 percent were created within the past
3 years. Table 2 of this document shows
that 53 percent of pending PMRs for
drug and biological products are in
response to the Pediatric Research and
Equity Act (PREA), under which FDA
requires sponsors to study new drugs,
when appropriate, for pediatric
populations. Under section 505B(a)(3) of
the FD&C Act, the initiation of these
studies generally is deferred until
required safety information from other
studies has first been submitted and
reviewed. PMRs for products approved
under the animal efficacy rule (21 CFR
314.600 for drugs; 21 CFR 601.90 for
biological products) can be conducted
only when the product is used for its
indication as a counterterrorism
measure. In the absence of a public
health emergency, these studies/clinical
trials will remain pending indefinitely.
The next largest category of pending
PMRs for drug and biological products
(45 percent) comprises those studies/
clinical trials required by FDA under
FDAAA, which became effective on
March 25, 2008.
Table 3 of this document provides
additional detail on the status of offschedule PMRs. The majority of offschedule PMRs (which account for 9
percent of the total for NDAs/ANDAs
and 12 percent for BLAs) are delayed
according to the original schedule
milestones (96 percent (47/49) for
NDAs/ANDAs; 94 percent (17/18) for
BLAs). In certain situations, the original
schedules may have been adjusted for
unanticipated delays in the progress of
the study/clinical trial (e.g., difficulties
with subject enrollment in a trial for a
marketed drug or need for additional
time to analyze results). In this report,
study/clinical trial status reflects the
status in relation to the original study/
clinical trial schedule regardless of
whether FDA has acknowledged that
additional time may be required to
complete the study/clinical trial.
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Tables 4 and 5 of this document
provide additional detail on the status
of PMCs. Table 4 of this document
provides additional detail on the status
of on-schedule PMCs. Pending PMCs
comprise 50 percent (201/399) of the onschedule NDA/ANDA PMCs and 28
percent (66/236) of the on-schedule BLA
PMCs.
Table 5 of this document provides
additional details on the status of off-
schedule PMCs. The majority of offschedule PMCs (which account for 16
percent for NDAs/ANDAs and 23
percent for BLAs) are delayed according
to the original schedule milestones (91
percent (67/74) for NDAs/ANDAs; 97
percent (69/71) for BLAs). As noted
previously in this document, this report
reflects the original due dates for study/
clinical trial results and does not reflect
discussions between the Agency and the
sponsor regarding studies/clinical trials
that may require more time for
completion.
Table 6 of this document provides
details about PMRs and PMCs that were
concluded in the previous year. The
majority of concluded PMRs and PMCs
were fulfilled (57 percent of NDA/
ANDA PMRs and 40 percent of BLA
PMRs; 85 percent of NDA/ANDA PMCs
and 84 percent of BLA PMCs).
TABLE 1—SUMMARY OF POSTMARKETING REQUIREMENTS AND COMMITMENTS
[Numbers as of September 30, 2010]
NDA/ANDA
(% of total PMR
or % of total
PMC)
BLA
(% of total PMR
or % of total
PMC) 1
526
477 (91%)
49 (9%)
473
399 (84%)
74 (16%)
149
131 (88%)
18 (12%)
307
236 (77%)
71 (23%)
Number of open PMRs ....................................................................................................................................
On-schedule open PMRs (see table 2 of this document) ........................................................................
Off-schedule open PMRs (see table 3 of this document) ........................................................................
Number of open PMCs ....................................................................................................................................
On-schedule open PMCs (see table 4 of this document) ........................................................................
Off-schedule open PMCs (see table 5 of this document) ........................................................................
1 On October 1, 2003, FDA completed a consolidation of certain therapeutic products formerly regulated by CBER into CDER. Consequently,
CDER now reviews many BLAs. Fiscal year statistics for postmarketing requirements and commitments for BLAs reviewed by CDER are included in BLA totals in this table.
TABLE 2—SUMMARY OF ON-SCHEDULE POSTMARKETING REQUIREMENTS
[Numbers as of September 30, 2010]
NDA/ANDA
(% of total PMR)
On-schedule open PMRs
Pending (by type):
Accelerated approval ................................................................................................................................
PREA 2 ......................................................................................................................................................
Animal efficacy 3 .......................................................................................................................................
FDAAA safety (since March 25, 2008) ....................................................................................................
BLA
(% of total
PMR) 1
7
217
1
145
2
27
0
62
Total ...................................................................................................................................................
Ongoing:
Accelerated approval ................................................................................................................................
PREA 2 ......................................................................................................................................................
Animal efficacy 3 .......................................................................................................................................
FDAAA safety (since March 25, 2008) ....................................................................................................
370 (70%)
91 (61%)
12
26
0
28
7
2
0
22
Total ...................................................................................................................................................
Submitted:
Accelerated approval ................................................................................................................................
PREA 2 ......................................................................................................................................................
Animal efficacy 3 .......................................................................................................................................
FDAAA safety (since March 25, 2008) ....................................................................................................
66 (13%)
31 (21%)
5
22
0
14
3
4
0
2
Total ...................................................................................................................................................
41 (8%)
9 (6%)
Combined total ..................................................................................................................................
477 (91%)
131 (88%)
1
See note 1 for table 1 of this document.
Many PREA studies have a pending status. PREA studies are usually deferred because the product is ready for approval in adults. Initiation
of these studies also may be deferred until additional safety information from other studies has first been submitted and reviewed.
3 PMRs for products approved under the animal efficacy rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) can be conducted only when the product is used for its indication as a counterterrorism measure. In the absence of a public health emergency, these studies/clinical trials will remain pending indefinitely.
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TABLE 3—SUMMARY OF OFF-SCHEDULE POSTMARKETING REQUIREMENTS
[Numbers as of September 30, 2010]
NDA/ANDA
(% of total PMR)
Off-schedule open PMRs
BLA
(% of total
PMR) 1
Delayed:
Accelerated approval ................................................................................................................................
PREA ........................................................................................................................................................
Animal efficacy .........................................................................................................................................
FDAAA safety (since March 25, 2008) ....................................................................................................
5
39
1
2
2
11
0
4
Total ...................................................................................................................................................
Terminated .......................................................................................................................................................
47 (9%)
2 (0.4%)
17 (11%)
1 (0.7%)
Combined total ..................................................................................................................................
49 (9%)
18 (12%)
1 See
note 1 for table 1 of this document.
TABLE 4—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS
[Numbers as of September 30, 2010]
NDA/ANDA
(% of total PMC)
On-schedule open PMCs
BLA
(% of total
PMC) 1
Pending ............................................................................................................................................................
Ongoing ...........................................................................................................................................................
Submitted .........................................................................................................................................................
201 (42%)
87 (18%)
111 (23%)
66 (21%)
95 (31%)
75 (24%)
Combined total .........................................................................................................................................
399 (84%)
236 (77%)
1 See
note 1 for table 1 of this document.
TABLE 5—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS
[Numbers as of September 30, 2010]
NDA/ANDA
(% of total PMC)
Off-schedule open PMCs
BLA
(% of total
PMC) 1
Delayed ............................................................................................................................................................
Terminated .......................................................................................................................................................
67 (14%)
7 (1%)
69 (22%)
2 (0.7%)
Combined total .........................................................................................................................................
74 (16%)
71 (23%)
1 See
note 1 for table 1 of this document.
TABLE 6—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS (OCTOBER 1, 2009 TO
OCTOBER 1, 2010)
NDA/ANDA
(% of total)
sroberts on DSK5SPTVN1PROD with NOTICES
Concluded PMRs:
Requirement met (fulfilled) .......................................................................................................................
Requirement not met (released and new revised requirement issued) ...................................................
Requirement no longer feasible or product withdrawn (released) ...........................................................
BLA
(% of total) 1
25 (57%)
10 (23%)
9 (20%)
4 (40%)
0
6 (60%)
Total ...................................................................................................................................................
Concluded PMCs:
Commitment met (fulfilled) .......................................................................................................................
Commitment not met (released and new revised requirement/commitment issued) ..............................
Commitment no longer feasible or product withdrawn (released) ...........................................................
44
10
174 (85%)
25 (12%)
5 (2%)
51 (84%)
1 (2%)
9 (15%)
Total ...................................................................................................................................................
204
61
1 See
note 1 for table 1 of this document.
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18:39 Aug 03, 2011
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Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Notices
Dated: August 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19806 Filed 8–3–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 76 FR 45584–45585
dated July 29, 2011).
This notice reflects organizational
changes to the Health Resources and
Services Administration. Specifically,
this notice updates the Division of
Vaccine Injury Compensation (RR4)
functional statement to better align
functional responsibility, improve the
management and delivery of
information technology services,
improve management and
administrative efficiencies, and
optimize use of available staff resources
within the Healthcare Systems Bureau
(RR).
Chapter RR—Healthcare Systems
Bureau
sroberts on DSK5SPTVN1PROD with NOTICES
Section RR–10, Organization
Delete in its entirety and replace with
the following:
The Healthcare Systems Bureau (RR)
is headed by the Associate
Administrator, who reports directly to
the Administrator, Health Resources
and Services Administration. The
Healthcare Systems Bureau includes the
following components:
(1) Office of the Associate
Administrator (RR);
(2) Division of Transplantation (RR1);
(3) Division of Health Facilities (RR9);
(4) Division of Vaccine Injury
Compensation (RR4); and
(5) Office of Pharmacy Affairs (RR7).
Section RR–20, Functions
(1) Delete the functional statement for
the Division of Vaccine Injury
Compensation (RR4) and replace in its
entirety.
Division of Vaccine Injury
Compensation (RR4)
The Division of Vaccine Injury
Compensation (DVIC), on behalf of the
VerDate Mar<15>2010
17:29 Aug 03, 2011
Jkt 223001
Secretary of Health and Human Services
(HHS), administers all statutory
authorities related to the operation of
the National Vaccine Injury
Compensation Program (VICP) by: (1)
Evaluating petitions for compensation
filed under the VICP through medical
review and assessment of
compensability for all complete claims;
(2) processing awards for compensations
made under the VICP; (3) promulgating
regulations to revise the Vaccine Injury
Table; (4) providing professional and
administrative support to the Advisory
Commission on Childhood Vaccines
(ACCV); (5) developing and maintaining
all automated information systems
necessary for program implementation;
(6) providing and disseminating
program information; (7) maintaining a
working relationship with the
Department of Justice (DOJ) and the U.S.
Court of Federal Claims (the Court) in
the administration and operation of the
VICP; (8) providing management,
direction, budgetary oversight,
coordination, and logistical support for
the Medical Expert Panel (MEP)
contracts as well as Clinical Reviewer
Contracts; (9) maintaining responsibility
for activities related to the ACCV, the
development of policy, regulations,
budget formulation, and legislation,
including the development and renewal
of the ACCV charter and action
memoranda to the Secretary, and the
analysis of the findings and proposals of
the ACCV; (10) developing, reviewing,
and analyzing pending and new
legislation relating to program changes,
new initiatives, the ACCV, and changes
to the Vaccine Injury Table, in
coordination with the Office of the
General Counsel (OGC); (11) providing
programmatic outreach efforts to
maximize public exposure to private
and public constituencies; (12)
providing submission of special reports
to the Secretary of HHS, the Office of
Management and Budget, the Congress,
and other governmental bodies; and (13)
providing the coordination of ACCV
travel, personnel, meeting sites, and its
agenda.
Section RR–30, Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this reorganization, and that are
consistent with this reorganization,
shall continue in effect pending further
re-delegation.
This reorganization is effective upon
date of signature.
PO 00000
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Dated: July 29, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011–19804 Filed 8–3–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Expediting Research Tools to NIH
Licensees Through the Use of Pay.gov
for Rapid Processing of Royalty
Payments
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
NIH licensees can now
expedite the receipt of research tools
through the use of Pay.gov for rapid
processing of their royalty payments.
SUPPLEMENTARY INFORMATION: With its
introduction earlier this year, NIH
licensees have found that using the new
royalty payment site within Pay.gov
expedites processing times for shipment
of their research tools licensed from the
NIH and FDA intramural research
programs. The value of such time
savings to corporate R&D programs is
not trivial since waiting too long to
secure research materials or tools can
delay or sink a critical drug
development program or other business
venture. By eliminating the need for
bank checks, the bank-to-bank transfer
system at Pay.gov has shortened the
processing time for research tool and
other license agreements from several
months down to a day or less. For
example, a recent transaction for
baculovirus vectors at NIH was indeed
processed in a single afternoon allowing
for almost instantaneous release of the
licensed materials from the inventors
laboratory.
Informal comments that NIH has
received to date from licensees who
have started to use Pay.gov for their
royalty payments include: ‘‘For Pay.gov,
it’s easy, convenient and fast, I guess
that’s what I experienced.’’, ‘‘It literally
only took me about 5 minutes after
reading the email/letter to process
payment. Great service!’’ and ‘‘I just
completed sending all the MAR
payments and it was great! I am glad I
decided to try the system.’’
Pay.gov itself is a multifaceted webbased application allowing anyone to
make Automated Clearing House (ACH)
payments to government agencies by
debit from a checking or savings
account. Pay.gov is open 24–7, and is
SUMMARY:
E:\FR\FM\04AUN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47211-47216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19806]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0332]
Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: Under the Food and Drug Administration Modernization Act of
1997 (Modernization Act), the Food and Drug Administration (FDA) is
required to report annually in the Federal Register on the status of
postmarketing requirements and commitments required of, or agreed upon
by, holders of approved drug and biological products. This notice is
the Agency's report on the status of the studies and clinical trials
that applicants have agreed to, or are required to, conduct.
FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6466, Silver Spring, MD 20993-0002, 301-
796-0700; or Stephen Ripley, Center for
[[Page 47212]]
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1400 Rockville Pike, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Modernization Act
Section 130(a) of the Modernization Act (Pub. L. 105-115) amended
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new
provision requiring reports of certain postmarketing studies, including
clinical trials, for human drug and biological products (section 506B
of the FD&C Act (21 U.S.C. 356b)). Section 506B of the FD&C Act
provides FDA with additional authority to monitor the progress of a
postmarketing study or clinical trial that an applicant has been
required to, or has agreed to, conduct by requiring the applicant to
submit a report annually providing information on the status of the
postmarketing study/clinical trial. This report must also include
reasons, if any, for failure to complete the study/clinical trial.
These studies and clinical trials are intended to further define the
safety, efficacy, or optimal use of a product, and therefore play a
vital role in fully characterizing the product.
Under the Modernization Act, commitments to conduct postmarketing
studies or clinical trials included both studies/clinical trials that
applicants agreed to conduct, as well as studies/clinical trials that
applicants were required to conduct under FDA regulations.\1\
---------------------------------------------------------------------------
\1\ Before passage of the Food and Drug Administration
Amendments Act of 2007 (FDAAA), FDA could require postmarketing
studies and clinical trials under the following circumstances: To
verify and describe clinical benefit for a human drug approved in
accordance with the accelerated approval provisions in section
506(b)(2)(A) of the FD&C Act (21 CFR 314.510 and 601.41); for a drug
approved on the basis of animal efficacy data because human efficacy
trials are not ethical or feasible (21 CFR 314.610(b)(1) and
601.91(b)(1)); and for marketed drugs that are not adequately
labeled for children under section 505B of the FD&C Act (Pediatric
Research Equity Act (21 U.S.C. 355c; Pub. L. 108-155)).
---------------------------------------------------------------------------
B. The Food and Drug Administration Amendments Act of 2007
On September 27, 2007, the President signed Public Law 110-85, the
Food and Drug Administration Amendments Act of 2007 (FDAAA). Section
901, in Title IX of FDAAA, created a new section 505(o) of the FD&C Act
authorizing FDA to require certain studies and clinical trials for
human drug and biological products approved under section 505 of the
FD&C Act or section 351 of the Public Health Service Act. Under FDAAA,
FDA has been given additional authority to require applicants to
conduct and report on postmarketing studies and clinical trials to
assess a known serious risk, assess signals of serious risk, or
identify an unexpected serious risk related to the use of a product.
This new authority became effective on March 25, 2008. FDA may now take
enforcement action against applicants who fail to conduct studies and
clinical trials required under FDAAA, as well as studies and clinical
trials required under FDA regulations (see sections 505(o)(1), 502(z),
and 303(f)(4) of the FD&C Act (21 U.S.C. 355(o)(1), 352(z), and
333(f)(4))).
Although regulations implementing the Modernization Act
postmarketing authorities use the term ``postmarketing commitment'' to
refer to both required studies and studies applicants agree to conduct,
in light of the new authorities enacted in FDAAA, FDA has decided it is
important to distinguish between enforceable postmarketing requirements
and unenforceable postmarketing commitments. Therefore, in this notice
and report, FDA refers to studies/clinical trials that an applicant is
required to conduct as ``postmarketing requirements'' (PMRs) and
studies/clinical trials that an applicant agrees to but is not required
to conduct as ``postmarketing commitments'' (PMCs). Both are addressed
in this notice and report.
C. FDA's Implementing Regulations
On October 30, 2000 (65 FR 64607), FDA published a final rule
implementing section 130 of the Modernization Act. This rule modified
the annual report requirements for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs) by revising Sec.
314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a
new annual reporting requirement for biologics license applications
(BLAs) by establishing Sec. 601.70 (21 CFR 601.70). The rule described
the content and format of the annual progress report, and clarified the
scope of the reporting requirement and the timing for submission of the
annual progress reports. The rule became effective on April 30, 2001.
The regulations apply only to human drug and biological products
approved under NDAs, ANDAs, and BLAs. They do not apply to animal drugs
or to biological products regulated under the medical device
authorities.
The reporting requirements under Sec. Sec. 314.81(b)(2)(vii) and
601.70 apply to PMRs and PMCs made on or before the enactment of the
Modernization Act (November 21, 1997), as well as those made after that
date. Therefore, studies and clinical trials required under FDAAA are
covered by the reporting requirements in these regulations.
Sections 314.81(b)(2)(vii) and 601.70 require applicants of
approved drug and biological products to submit annually a report on
the status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study/clinical trial either
required by FDA or that they have committed to conduct, either at the
time of approval or after approval of their NDA, ANDA, or BLA. The
status of PMCs concerning chemistry, manufacturing, and production
controls and the status of other studies/clinical trials conducted on
an applicant's own initiative are not required to be reported under
Sec. Sec. 314.81(b)(2)(vii) and 601.70 and are not addressed in this
report. It should be noted, however, that applicants are required to
report to FDA on these commitments made for NDAs and ANDAs under Sec.
314.81(b)(2)(viii). Furthermore, section 505(o)(3)(E) of the FD&C Act,
as amended by FDAAA, requires that applicants report periodically on
the status of each required study/clinical trial and each study/
clinical trial ``otherwise undertaken * * * to investigate a safety
issue * * *.''
According to the regulations, once a PMR has been required, or a
PMC has been agreed upon, an applicant must report on the progress of
the PMR/PMC on the anniversary of the product's approval until the PMR/
PMC is completed or terminated and FDA determines that the PMR/PMC has
been fulfilled or that the PMR/PMC is either no longer feasible or
would no longer provide useful information. The annual progress report
must include a description of the PMR/PMC, a schedule for completing
the PMR/PMC, and a characterization of the current status of the PMR/
PMC. The report must also provide an explanation of the PMR/PMC status
by describing briefly the progress of the PMR/PMC. A PMR/PMC schedule
is expected to include the actual or projected dates for the following:
(1) Submission of the final protocol to FDA, (2) completion of the
study/clinical trial, and (3) submission of the final report to FDA.
The status of the PMR/PMC must be described in the annual report
according to the following definitions:
Pending: The study/clinical trial has not been initiated
(i.e., no subjects have been enrolled or animals dosed), but does not
meet the criteria for delayed (i.e., the original projected date for
initiation of subject accrual or
[[Page 47213]]
initiation of animal dosing has not passed);
Ongoing: The study/clinical trial is proceeding according
to or ahead of the original schedule;
Delayed: The study/clinical trial is behind the original
schedule;
Terminated: The study/clinical trial was ended before
completion, but a final report has not been submitted to FDA; or
Submitted: The study/clinical trial has been completed or
terminated, and a final report has been submitted to FDA.
Databases containing information on PMRs/PMCs are maintained at the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER).
II. Summary of Information From Postmarketing Status Reports
This report, published to fulfill the annual reporting requirement
under the Modernization Act, summarizes the status of PMRs and PMCs as
of September 30, 2010. If a requirement or commitment did not have a
schedule, or a postmarketing progress report was not received in the
previous 12 months, the PMR/PMC is categorized according to the most
recent information available to the Agency.\2\
---------------------------------------------------------------------------
\2\ Although the data included in this report do not include a
summary of reports that applicants have failed to file by their due
date, the Agency notes that it may take appropriate regulatory
action in the event reports are not filed on a timely basis.
---------------------------------------------------------------------------
Information in this report covers any PMR/PMC that was made, in
writing, at the time of approval or after approval of an application or
a supplement to an application, including PMRs required under FDAAA
(section 505(o)(3) of the FD&C Act), PMRs required under FDA
regulations (e.g., PMRs required to demonstrate clinical benefit of a
product following accelerated approval (see footnote 1 of this
document)), and PMCs agreed to by the applicant.
Information summarized in this report includes the following: (1)
The number of applicants with open (uncompleted) PMRs/PMCs, (2) the
number of open PMRs/PMCs, (3) the status of open PMRs/PMCs as reported
in Sec. 314.81(b)(2)(vii) or Sec. 601.70 annual reports, (4) the
status of concluded PMRs/PMCs as determined by FDA, and (5) the number
of applications with open PMRs/PMCs for which applicants did not submit
an annual report within 60 days of the anniversary date of U.S.
approval.
Additional information about PMRs/PMCs submitted by applicants to
CDER and CBER is provided on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm. Neither the Web site nor this
notice include information about PMCs concerning chemistry,
manufacturing, and controls. It is FDA policy not to post information
on the Web site until it has been reviewed for accuracy. Numbers
published in this notice cannot be compared with the numbers resulting
from searches of the Web site because this notice incorporates totals
for all PMRs/PMCs in FDA databases, including PMRs/PMCs undergoing
review for accuracy. In addition, the report in this notice will be
updated annually while the Web site is updated quarterly (i.e., in
January, April, July, and October).
Many applicants have more than one approved product and for many
products there is more than one PMR or PMC. Specifically, there were
164 unique applicants with 233 NDAs/ANDAs that had open PMRs/PMCs.
There were 69 unique applicants with 87 BLAs that had open PMRs/PMCs.
Annual status reports are required to be submitted for each open
PMR/PMC within 60 days of the anniversary date of U.S. approval of the
original application. In fiscal year 2010 (FY10), 20 percent (36/184)
of NDA/ANDA and 36 percent (31/87) of BLA annual status reports were
not submitted within 60 days of the anniversary date of U.S. approval
of the original application. Of the annual status reports due but not
submitted on time, 100 percent of the NDA/ANDA and 52 percent (16/31)
of the BLA reports were submitted before the close of FY10 (September
30, 2010).
Most PMRs are progressing on schedule (91 percent for NDAs/ANDAs;
88 percent for BLAs). Most PMCs are also progressing on schedule (84
percent for NDAs/ANDAs; 77 percent for BLAs). Most of the PMCs that are
currently listed in the database were developed before the
postmarketing requirements section of FDAAA took effect.\3\
---------------------------------------------------------------------------
\3\ There are existing PMCs established before FDAAA that might
meet current FDAAA standards for required safety studies/clinical
trials under section 505(o)(3)(B) of the FD&C Act. Under section
505(o)(3)(c) of the FD&C Act, the Agency may convert pre-existing
PMCs into PMRs if it becomes aware of new safety information.
---------------------------------------------------------------------------
III. About This Report
This report provides six separate summary tables. The tables in
this document distinguish between PMRs and PMCs and between on-schedule
and off-schedule PMRs and PMCs according to the original schedule
milestones. On-schedule PMRs/PMCs are categorized as pending, ongoing,
or submitted. Off-schedule PMRs/PMCs that have missed one of the
original milestone dates are categorized as delayed or terminated. The
tables include data as of September 30, 2010.
Table 1 of this document provides an overall summary of the data on
all PMRs and PMCs. Tables 2 and 3 of this document provide detail on
PMRs. Table 2 of this document provides additional detail on the status
of on-schedule PMRs.
Table 1 of this document shows that most PMRs (91 percent for NDAs/
ANDAs and 88 percent for BLAs) and most PMCs (84 percent for NDAs/ANDAs
and 77 percent for BLAs) are on schedule. Overall, of the PMRs that are
pending (i.e., have not been initiated), 92 percent were created within
the past 3 years. Table 2 of this document shows that 53 percent of
pending PMRs for drug and biological products are in response to the
Pediatric Research and Equity Act (PREA), under which FDA requires
sponsors to study new drugs, when appropriate, for pediatric
populations. Under section 505B(a)(3) of the FD&C Act, the initiation
of these studies generally is deferred until required safety
information from other studies has first been submitted and reviewed.
PMRs for products approved under the animal efficacy rule (21 CFR
314.600 for drugs; 21 CFR 601.90 for biological products) can be
conducted only when the product is used for its indication as a
counterterrorism measure. In the absence of a public health emergency,
these studies/clinical trials will remain pending indefinitely. The
next largest category of pending PMRs for drug and biological products
(45 percent) comprises those studies/clinical trials required by FDA
under FDAAA, which became effective on March 25, 2008.
Table 3 of this document provides additional detail on the status
of off-schedule PMRs. The majority of off-schedule PMRs (which account
for 9 percent of the total for NDAs/ANDAs and 12 percent for BLAs) are
delayed according to the original schedule milestones (96 percent (47/
49) for NDAs/ANDAs; 94 percent (17/18) for BLAs). In certain
situations, the original schedules may have been adjusted for
unanticipated delays in the progress of the study/clinical trial (e.g.,
difficulties with subject enrollment in a trial for a marketed drug or
need for additional time to analyze results). In this report, study/
clinical trial status reflects the status in relation to the original
study/clinical trial schedule regardless of whether FDA has
acknowledged that additional time may be required to complete the
study/clinical trial.
[[Page 47214]]
Tables 4 and 5 of this document provide additional detail on the
status of PMCs. Table 4 of this document provides additional detail on
the status of on-schedule PMCs. Pending PMCs comprise 50 percent (201/
399) of the on-schedule NDA/ANDA PMCs and 28 percent (66/236) of the
on-schedule BLA PMCs.
Table 5 of this document provides additional details on the status
of off-schedule PMCs. The majority of off-schedule PMCs (which account
for 16 percent for NDAs/ANDAs and 23 percent for BLAs) are delayed
according to the original schedule milestones (91 percent (67/74) for
NDAs/ANDAs; 97 percent (69/71) for BLAs). As noted previously in this
document, this report reflects the original due dates for study/
clinical trial results and does not reflect discussions between the
Agency and the sponsor regarding studies/clinical trials that may
require more time for completion.
Table 6 of this document provides details about PMRs and PMCs that
were concluded in the previous year. The majority of concluded PMRs and
PMCs were fulfilled (57 percent of NDA/ANDA PMRs and 40 percent of BLA
PMRs; 85 percent of NDA/ANDA PMCs and 84 percent of BLA PMCs).
Table 1--Summary of Postmarketing Requirements and Commitments
[Numbers as of September 30, 2010]
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of total
total PMR or % PMR or % of
of total PMC) total PMC) \1\
------------------------------------------------------------------------
Number of open PMRs................. 526 149
On-schedule open PMRs (see table 477 (91%) 131 (88%)
2 of this document)............
Off-schedule open PMRs (see 49 (9%) 18 (12%)
table 3 of this document)......
Number of open PMCs................. 473 307
On-schedule open PMCs (see table 399 (84%) 236 (77%)
4 of this document)............
Off-schedule open PMCs (see 74 (16%) 71 (23%)
table 5 of this document)......
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
therapeutic products formerly regulated by CBER into CDER.
Consequently, CDER now reviews many BLAs. Fiscal year statistics for
postmarketing requirements and commitments for BLAs reviewed by CDER
are included in BLA totals in this table.
Table 2--Summary of On-Schedule Postmarketing Requirements
[Numbers as of September 30, 2010]
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of total
On-schedule open PMRs total PMR) PMR) \1\
------------------------------------------------------------------------
Pending (by type):
Accelerated approval............ 7 2
PREA \2\........................ 217 27
Animal efficacy \3\............. 1 0
FDAAA safety (since March 25, 145 62
2008)..........................
-----------------------------------
Total....................... 370 (70%) 91 (61%)
Ongoing:
Accelerated approval............ 12 7
PREA \2\........................ 26 2
Animal efficacy \3\............. 0 0
FDAAA safety (since March 25, 28 22
2008)..........................
-----------------------------------
Total....................... 66 (13%) 31 (21%)
Submitted:
Accelerated approval............ 5 3
PREA \2\........................ 22 4
Animal efficacy \3\............. 0 0
FDAAA safety (since March 25, 14 2
2008)..........................
-----------------------------------
Total....................... 41 (8%) 9 (6%)
===================================
Combined total.............. 477 (91%) 131 (88%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
\2\ Many PREA studies have a pending status. PREA studies are usually
deferred because the product is ready for approval in adults.
Initiation of these studies also may be deferred until additional
safety information from other studies has first been submitted and
reviewed.
\3\ PMRs for products approved under the animal efficacy rule (21 CFR
314.600 for drugs; 21 CFR 601.90 for biological products) can be
conducted only when the product is used for its indication as a
counterterrorism measure. In the absence of a public health emergency,
these studies/clinical trials will remain pending indefinitely.
[[Page 47215]]
Table 3--Summary of Off-Schedule Postmarketing Requirements
[Numbers as of September 30, 2010]
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of total
Off-schedule open PMRs total PMR) PMR) \1\
------------------------------------------------------------------------
Delayed:
Accelerated approval............ 5 2
PREA............................ 39 11
Animal efficacy................. 1 0
FDAAA safety (since March 25, 2 4
2008)..........................
-----------------------------------
Total....................... 47 (9%) 17 (11%)
Terminated.......................... 2 (0.4%) 1 (0.7%)
-----------------------------------
Combined total.............. 49 (9%) 18 (12%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
Table 4--Summary of On-Schedule Postmarketing Commitments
[Numbers as of September 30, 2010]
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of total
On-schedule open PMCs total PMC) PMC) \1\
------------------------------------------------------------------------
Pending............................. 201 (42%) 66 (21%)
Ongoing............................. 87 (18%) 95 (31%)
Submitted........................... 111 (23%) 75 (24%)
-----------------------------------
Combined total.................. 399 (84%) 236 (77%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
Table 5--Summary of Off-Schedule Postmarketing Commitments
[Numbers as of September 30, 2010]
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of total
Off-schedule open PMCs total PMC) PMC) \1\
------------------------------------------------------------------------
Delayed............................. 67 (14%) 69 (22%)
Terminated.......................... 7 (1%) 2 (0.7%)
-----------------------------------
Combined total.................. 74 (16%) 71 (23%)
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
Table 6--Summary of Concluded Postmarketing Requirements and Commitments
(October 1, 2009 to October 1, 2010)
------------------------------------------------------------------------
NDA/ANDA (% of BLA (% of
total) total) \1\
------------------------------------------------------------------------
Concluded PMRs:
Requirement met (fulfilled)..... 25 (57%) 4 (40%)
Requirement not met (released 10 (23%) 0
and new revised requirement
issued)........................
Requirement no longer feasible 9 (20%) 6 (60%)
or product withdrawn (released)
-----------------------------------
Total....................... 44 10
Concluded PMCs:
Commitment met (fulfilled)...... 174 (85%) 51 (84%)
Commitment not met (released and 25 (12%) 1 (2%)
new revised requirement/
commitment issued).............
Commitment no longer feasible or 5 (2%) 9 (15%)
product withdrawn (released)...
-----------------------------------
Total....................... 204 61
------------------------------------------------------------------------
\1\ See note 1 for table 1 of this document.
[[Page 47216]]
Dated: August 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19806 Filed 8-3-11; 8:45 am]
BILLING CODE 4160-01-P
